Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

Endpoint summary

Description of key information

LD50(oral) = ca. 2000 mg/kg (BASF, 2008)
LD50(dermal) > 2000 mg/kg (BASF, 2010)

Additional information

Acute oral toxicity:

The acute toxicity following oral administration of LIMUS-Sambaydestillation was assessed in Wistar rats in a study according to OECD 423 guideline and GLP (BASF, 2008). Single doses of 2000 and 300 mg/kg body weight of the test material preparations in doubly distilled water were given to four test groups of three fasted female animals each, (2000 mg/kg in 6 females, 300 mg/kg in 6 females) by gavage in a sequential manner. One animal of the first 2000 mg/kg test group was found dead at hour 3 after administration. Two animals of the second 2000 mg/kg test groups were found dead at hour 2 and hour 3 after administration. No mortality occurred in the 300 mg/kg test groups. Clinical observation in the 2000 mg/kg test groups revealed impaired and poor general state, dyspnoea, piloerection, exsiccosis, staggering, salivation, ataxia and reduced feces. Findings were observed from hour 0 through to study day 10 after administration. Clinical observation in the 300 mg/kg test group revealed impaired general state, dyspnoea, piloerection and reduced feces. Findings were observed from hour 0 through to study day 6 after administration. The mean body weights of the surviving animals increased normally throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation (2000 mg/kg: 3 females; 300 mg/kg: 6 females). At necropsy the animals that died showed bilateral hydrothorax (ca. 2 mL), edema in all lobes of lung, dark spotted discoloration of all lobes of lung and congestion in heart, kidneys, stomach and intestine (2000 mg/kg: 3 females). Under the conditions of this study the median lethal dose of LIMUS-Sambaydestillation after oral administration was found to be ca. 2000 mg/kg body weight in rats.

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test) according to OECD 402 guideline and GLP (BASF, 2010), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of LIMUS Sambaydestillation (as suspension in olive oil Ph.Eur.) to the clipped skin (dorsal and dorso-Iateral parts of the trunk) and covered by semi occlusive dressing for 24 hours.

The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) in rats was determined to be > 2000 mg/kg bw.

No signs of systemic toxicity or skin effects were observed in the animals.

The mean body weight of the animals increased within the normal range throughout the study period.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity studies, the substance was classified R22 (according to Directive 67/548/EEC) and Acute toxicity oral Cat 4 (according to CLP).